The requirements of the Falsified Medicines Directive (FMD) adopted in July 2011 have been widely reported, largely in relation to the safety features requirements of the Directive relating to the provisions for tamper evidence and unique pack identification.
While the latter issues have been the more widely reported, relatively little attention has been paid to the provisions in the Directive related to tightening the active pharmaceutical ingredient supply chain and to application of Good Manufacturing Practice (GMP) to certain excipients.
The API provisions require Member States to take appropriate measures to ensure that manufacturers of active substances on their territory comply GMP for active substances (to be defined in a delegated act developed by the Commission), require member states to register importers of APIs from third countries outside the EU and sets out requirements for importation of APIs from third countries to ensure compliance of the manufacture of APIs with GMP.
With regard to excipients, the Directive requires the holders of the manufacturing authorisations to ensure that the excipients are suitable for use in medicinal products by ascertaining what the appropriate good manufacturing practice is for individual excipients based on a formalised risk assessment in accordance with the applicable guidelines to be developed by the Commission.
the Directive requires the holders of the manufacturing authorisations to ensure that the excipients are suitable for use in medicinal products
On the delegated act on GMP for APIs the Commission recently issued for consultation a concept paper at ec.europa.eu/health/files/gmp/2012_01_20_gmp_cp_en.pdf, which describes how it intends to go about this task (largely by appropriate extension and amendment of the current GMP Directive2003/94).
As regards the importation of APIs from third countries, one of the options of the FMD is by importation from a country included on a list produced by the Commission to include those countries which the Commission deems as providing the same level of control of GMP for APIs as the EU. Another concept paper ec.europa.eu/health/files/counterf_par_trade/api_import.pdf sets out its thoughts in relation to establishing equivalence of third countries for inclusion on such a list.
The development of these important legislative instruments will be followed closely by all interested parties.
